The present invention relates to ampule systems for maintaining components, particularly reactive components and reagents, separated until immediately prior to use. It finds particular application in conjunction with sterilant systems in which a peracetic sterilant as well as buffers and corrosion inhibitors are diluted or dissolved immediately prior to a sterilizing operation. However, it is to be appreciated that the present invention will find utility in other multi-component systems which are intermixed in preparation for use, such as photographic systems, coating systems, medications, and the like.
Heretofore, most medical facilities have used steam autoclave sterilization systems. Commonly, medical instruments and equipment were transported to a central sterilizing facility where they were sterilized under the supervision of sterilizing room technicians. In a steam autoclave, which typically has a cycle time of one to two hours, the equipment was subject to superheated steam at high pressures. After an appropriate sterilizing duration, the autoclave was depressurized and cooled.
Instruments and equipment which could not withstand the temperature of an autoclave were commonly sterilized with ethylene oxide gas. After the equipment was sealed in a sterilizing chamber, the highly toxic ethylene oxide gas was introduced under pressure and allowed to remain for a couple of hours, as was appropriate to the selected sterilizing cycle. After the sterilizing cycle, the equipment could not be utilized until absorbed ethylene oxide was removed. This generally required about 12 to 16 hours in a vacuum or about 72 hours in ambient atmospheric conditions.
Liquid sterilization systems were also available for equipment which could not withstand the autoclave or the ethylene oxide systems. However, most were manually performed. That is, the equipment was immersed in a vat or tank that had been filled with a sterilizing solution, such as stabilized hydrogen peroxide or glutaraldehyde. However, because long immersion times on the order of 6 to 10 hours, were commonly required for sterilization, the liquid systems were more commonly used for disinfecting. Because the liquid sterilizing or disinfecting agents were toxic to human tissue, the equipment had to be rinsed before it could be used with human patients. Frequently, non-sterile tap water was used as the rinse.
Sterilization connotes the absence of all life forms including bacterial endospores which are the living organisms most resistant to known sterilants. By contrast, disinfection only connotes the absence of pathogenic life forms. As is to be appreciated, establishing the absence of all life forms for sterilization is more readily documented and controlled than the elimination of pathogenic but not all life forms for disinfection.
Because bacterial spores are the life form which is most resistant to sterilants, they are commonly used as a reproducible, stable indicators of the effectiveness of a sterilization product. For medical sterilizers, a sterility assurance level (SAL) of less than or equal to one chance in one million of having an item contaminated by a bacteria spore is generally regarded as the minimum acceptable level for medical devices. In practice, this level of assurance is obtained by a establishing the exposure time required to sterilize a given quantity of bacterial endospores known to be resistant to the sterilant. The destruction rate of the spore is commonly logrythmic. From the logrythmic destruction rate, commonly denoted by a D value, the exposure time required for an insurance level of one in a million (10.sup.-6) can be readily calculated. Because pathogenic microorganisms, which are mostly vegetative forms of bacteria, do not have the stability to derive a D value or its equivalent, there is no readily available biological indicator to show the effectiveness of a disinfectant.
In accordance with the present invention, a new and improved reactive agent dispensing system is provided which overcomes the above referenced sterilizer problems and analogous problems and other equipment in which reactive agents are released contemporaneously with use.